Reported Earlier, Duality Biologics And BioNtech Reveals Interim Results For B7-H3 Antibody-Drug Conjugate BNT324/DB-1311 In Advanced Solid Tumors At ESMO Asia Congress 2024
Reported Earlier, Duality Biologics And BioNtech Reveals Interim Results For B7-H3 Antibody-Drug Conjugate BNT324/DB-1311 In Advanced Solid Tumors At ESMO Asia Congress 2024
早些时候报道，Duality 生物制品和 biontech 在2024年ESMO 亚洲大会上揭示了B7-H3抗体药物结合物BNT324/Db-1311在爱文思控股晚期实体肿瘤中的中期结果。
- BNT324/DB-1311 showed encouraging antitumor activity and a manageable safety profile in a Phase 1/2a clinical trial in heavily pretreated patients with locally advanced or metastatic solid tumors, including small cell lung cancer ("SCLC"), non-small cell lung cancer ("NSCLC"), and castration-resistant prostate cancer ("CRPC").
- In patients with SCLC with at least one post-baseline tumor assessment and who had received prior immunotherapy but no prior topoisomerase 1 inhibitor, the unconfirmed objective response rate ("uORR") was 70.4% at the BNT324/DB-1311 9 mg/kg dose level.
- In patients with CRPC, the uORR was 28.0%; imaging progression-free survival ("rPFS") data are not yet mature, with a median rPFS of 7.2 months and a 6-month rPFS rate of 94.7%.
- Multiple clinical trials combining selected assets from BioNTech's and DualityBio's strategic partnership with BNT327/PM8002, an investigational bispecific antibody targeting PD-L1 and VEGF-A, are planned; a Phase 1/2 trial evaluating BNT324/DB-1311 with BNT327/PM8002 in patients with SCLC or NSCLC is planned to start in 2025.
- BNT324/Db-1311在一项针对重度预处理患者的1/2a期临床试验中显示出良好的抗肿瘤活性和可管理的安全性，患者包括局部晚期或转移性实体肿瘤患者，涵盖小细胞肺癌（"SCLC"）、非小细胞肺癌（"NSCLC"）和去势抵抗性前列腺癌（"CRPC"）。
- 在接受过免疫治疗但未接受过拓扑异构酶1抑制剂的SCLC患者中，至少有一次基线后的肿瘤评估，在BNT324/Db-1311 9 mg/kg剂量水平下，未确认的客观反应率（"uORR"）为70.4%。
- 在CRPC患者中，uORR为28.0%；影像学进展免费生存期（"rPFS"）数据尚未成熟，中位rPFS为7.2个月，6个月rPFS率为94.7%。
- 多个临床试验计划结合BioNTech与DualityBio的战略合作中选定的资产与BNT327/PM8002，这是一种针对PD-L1和VEGF-A的 investigación bispecific抗体；计划于2025年开始在SCLC或NSCLC患者中评估BNT324/Db-1311与BNT327/PM8002的1/2期试验。
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